K823341 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT SET TAG-GK. This device is classified as a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I - General Controls, product code CDT).
Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982, 44 days after receiving the submission on November 8, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K823341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1982 |
| Decision Date | December 22, 1982 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |